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Physiology of GERD and Treatment Response

Sponsor
University of California, Davis (Other)
Overall Status
Completed
CT.gov ID
NCT04292470
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH)
7
Enrollment
1
Location
1
Arm
12
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to assess the physiologic and behavioral mechanisms associated with enhanced medication effects in adult patients with functional GERD-related symptoms.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Subjects will complete questionnaires regarding their GERD-related symptoms and have a visit with a study clinician regarding their symptoms. Heart rate variability and galvanic skin response will be measured in the patient-provider dyads and the visits video recorded. Subjects will receive a two-month supply of amitriptyline (10 mg/day), along with instructions for taking it. Subjects will complete a daily GERD symptom diary during the first and eighth weeks of the study. At the end of the 8-week observation period, subjects will complete follow-up measures of GERD symptom severity and quality of life.

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Physiology of GERD and Treatment Response
Actual Study Start Date :
Nov 5, 2020
Actual Primary Completion Date :
Nov 4, 2021
Actual Study Completion Date :
Nov 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Amitriptyline

Amitriptyline 10 mg daily

Drug: Amitriptyline
Amitriptyline tablet

Outcome Measures

Primary Outcome Measures

  1. Change in GERD symptoms [8 weeks (study visit 1 to study visit 2)]

    Average daily GERD symptom severity during the last 7 days of the study compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day is based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms.

Secondary Outcome Measures

  1. Correlation of physiologic concordance with GERD symptom change [8 weeks (study visit 1 to study visit 2)]

    Ratio of the sum of positive correlations over the sum of negative correlations in GSR (or HRV) across patient-provider encounters and for responders vs. non-responders (those with a 50% or greater improvement in their GERD symptom severity).

Eligibility Criteria

Criteria

Ages Eligible for Study:
24 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Adults ages 24-64 years old

  • Functional heartburn (defined as <4% of time with reflux on 24 hour pH manometry) symptoms 3 or more days per week with an average daily symptom severity of 3 or more on a 7-day baseline symptom diary

  • English language proficiency

  • Willingness to be videotaped and connected to physiologic monitoring devices during the visit

  • Willingness to take amitriptyline daily for 8 weeks following study visit 1

Exclusion Criteria:

  • Diagnosis of Crohn's disease, systemic sclerosis, known active ulcer disease, gastric cancer, or untreated/active Barrett's esophagitis based on subject self-report and/or medical record review

  • Heavy alcohol use (> 6 drinks/week for women and > 13 drinks/week for men) based on subject self-report

  • Pregnant, attempting to become pregnant, or breast-feeding

  • Dementia or significant memory difficulties as determined by the study team and medical record review

  • Severe, unstable psychiatric disease based on subject self-report, study team determination, and/or medical record review

  • Bipolar disorder, concurrent treatment with a SSRI or another antidepressant that interacts with tricyclic antidepressants

  • Prolonged QTc or severe heart disease

  • History of seizure disorder

  • Severe liver impairment - e.g., cirrhosis, hepatocellular carcinoma, hepatitis

  • Currently taking a tricyclic antidepressant, allergy to tricyclic antidepressants, or another medical contraindication to taking amitriptyline or related medications

  • Greater than 15 doses of nonsteroidal anti-inflammatory drugs (NSAIDS) within the prior 30 days (aspirin ≤ 325 mg daily permitted) or ongoing NSAID use at a level deemed likely to interfere with the study

  • Failure to complete the baseline symptom diary for at least 6 of 7 days

  • Change in GERD treatment regimen within the last 2 weeks (subjects may use antacids, H2 receptor blockers, and/or proton pump inhibitors as long as they are symptomatic on a stable regimen)

  • Allergy to adhesives

  • Inability to provide informed consent

  • In the opinion of the investigator, unable to comply with the study protocol or has a condition that would likely interfere with the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California Davis Medical Center Sacramento California United States 95817

Sponsors and Collaborators

  • University of California, Davis
  • National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Michelle Dossett, MD, PhD, MPH, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT04292470
Other Study ID Numbers:
  • 1485210
  • K23AT009218
First Posted:
Mar 3, 2020
Last Update Posted:
Feb 7, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gastroesophageal Reflux
Amitriptyline

Study Results

No Results Posted as of Feb 7, 2022